Abstract

VALIDATION STUDY FOR SIMULTANEOUS ESTIMATION OF LORATADINE AND PSEUDOEPHEDRINE SULFATE IN TABLET DOSAGE FORM BY RP-HPLC

Komal Arjun Siddhanti*, Bhumi Patel, Dhwani Shah, Jaymin Patel and Ketul Prajapati

ABSTRACT

A simple, rapid, precise and accurate Stability indicating RP-HPLC method for simultaneous estimation of Loratadine And Pseudoephedrine Sulfate in their Combined Dosage Form has been developed. A reverse phase high performance liquid chromatographic method was developed for the simultaneous estimation of Loratadine and Pseudoephedrine Sulfate in their Combined Dosage Form. The separation was achieved by LC- 20 AT C18 (25cm x 0.46 cm) column and Buffer (Potassium Phosphate, pH 5.0) : Acetonitrile (70:30%v/v) as mobile phase, at a flow rate of 1 ml/min. Detection was carried out at 240 nm. Retention time of Loratadine and Pseudoephedrine Sulfate were found to be 5.737 min and 3.300 min respectively. The method has been validated for linearity, accuracy and precision. Linearity observed for Loratadine 0.5-1.5 μg/ml and for Pseudoephedrine Sulfate 12-36 μg/ml. Developed method was found to be accurate, precise and rapid for simultaneous estimation of Loratadine And Pseudoephedrine Sulfate in their Combined Dosage Form. The proposed method was successfully applied for the simultaneous estimation of both the drugs in commercial Combined dosage form.

Keywords: Loratadine, Psedoephedrine Sulfate, Stability indicating RP-HPLC Method, Validation.